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AuthorAlshaer, Walhan
AuthorNsairat, Hamdi
AuthorLafi, Zainab
AuthorHourani, Omar M.
AuthorAl-Kadash, Abdulfattah
AuthorEsawi, Ezaldeen
AuthorAlkilany, Alaaldin M.
Available date2023-10-15T11:12:25Z
Publication Date2022-12-20
Publication NameMolecules
Identifierhttp://dx.doi.org/10.3390/molecules28010010
CitationAlshaer, W., Nsairat, H., Lafi, Z., Hourani, O. M., Al-Kadash, A., Esawi, E., & Alkilany, A. M. (2022). Quality by design approach in liposomal formulations: Robust product development. Molecules, 28(1), 10.
URIhttps://www.scopus.com/inward/record.uri?partnerID=HzOxMe3b&scp=85145708347&origin=inward
URIhttp://hdl.handle.net/10576/48508
AbstractNanomedicine is an emerging field with continuous growth and differentiation. Liposomal formulations are a major platform in nanomedicine, with more than fifteen FDA-approved liposomal products in the market. However, as is the case for other types of nanoparticle-based delivery systems, liposomal formulations and manufacturing is intrinsically complex and associated with a set of dependent and independent variables, rendering experiential optimization a tedious process in general. Quality by design (QbD) is a powerful approach that can be applied in such complex systems to facilitate product development and ensure reproducible manufacturing processes, which are an essential pre-requisite for efficient and safe therapeutics. Input variables (related to materials, processes and experiment design) and the quality attributes for the final liposomal product should follow a systematic and planned experimental design to identify critical variables and optimal formulations/processes, where these elements are subjected to risk assessment. This review discusses the current practices that employ QbD in developing liposomal-based nano-pharmaceuticals.
Languageen
PublisherMultidisciplinary Digital Publishing Institute (MDPI)
Subjectdrug delivery
liposomes
nano-pharmaceuticals
nanomedicine
pharmaceutical industry
quality by Design (QbD)
TitleQuality by Design Approach in Liposomal Formulations: Robust Product Development
TypeArticle
Issue Number1
Volume Number28
ESSN1420-3049
dc.accessType Open Access


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